Valve Component, Frame Component and Prosthetic Valve Device Including the Same for Implantation in a Body Lumen

ABSTRACT

Described herein is a prosthetic valve device having an optimized valve component for durability and functionality of the collapsible leaflets. Specially designed commissures contribute to the optimization along with identified parameters. In other embodiments, the invention is a frame formed from a unique cutting pattern.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/539,173, filed Nov. 12, 2014, which is a continuation ofU.S. patent application Ser. No. 13/637,282, filed Jan. 23, 2013, nowU.S. Pat. No. 8,992,599; which is a U.S. National Application under 35U.S.C. §371 of PCT Application No. PCT/US2011/030217, filed Mar. 28,2011, which in turn claims the benefit of U.S. Provisional PatentApplication Ser. No. 61/318,218, filed Mar. 26, 2010, the entireties ofwhich are hereby incorporated herein by reference.

FIELD OF THE DISCLOSURE

The present invention relates generally to prosthetic valve devices forimplantation into a body lumen, and specifically to prosthetic valvedevices, and components thereof, for implantation into a body lumen viatransluminal delivery. While not so limited, the present invention isparticularly suited for use in replacing a native heart valve or afailing prosthetic heart valve previously implanted within a patient.

BACKGROUND

Heart valve disease continues to be a significant cause of morbidity andmortality. Heart valve replacement has become a routine surgicalprocedure for patients suffering from valve regurgitation or stenoticcalcification of the leaflets. Until recently, the vast majority ofheart valve replacements entailed full sternotomy and placing thepatient on cardiopulmonary bypass. Traditional open surgery inflictssignificant patient trauma and discomfort, requires extensiverecuperation times and may result in life-threatening complications. Toaddress these concerns, within the last fifteen years efforts have beenmade to perform cardiac valve replacements using minimally-invasivetechniques, such as a percutaneous entry with a transluminal delivery.These surgical techniques, generally referred to as percutaneous heartvalve replacement therapies (PHVT), use a catheter to deliver aprosthetic valve device to an implantation site using a patients' lumenof the vascular system.

In general, two types of prosthetic heart valve devices are used in theindustry to replace defective native heart valves (or a previouslyimplanted prosthetic heart valve that are failing): mechanicalprosthetic valve devices and biological prosthetic valve devices.Biological prosthetic valve devices use a natural tissue, typically ofporcine or human origin, to form the collapsible leaflets of thebiological prosthetic valve device.

While great efforts have been put into developing prosthetic valvedevices for cardiac and other body lumens, existing prosthetic valvedevices suffer from a number of drawbacks, including premature failuredue to wear, complexity of manufacture, and less than optimalperformance. Such deficiencies are present both in the valve componentand the frame of existing prosthetic valve devices. For example,deficiencies in existing valve components include without limitation:(1) the working leaflets and fluid passageway of the valve componentbeing subjected to anchoring penetrations that can cause premature wear;(2) less than optimal leaflet design that can result in inferior sealingof the fluid passageway; (3) less than optimal leaflet design that canresult in undesirable overlap and/or crimping of the collapsibleleaflets during a closure state; and (4) complexity of the leaflet.Deficiencies in the frames, which can act as stent components wheninstalled, include without limitation: (1) complexity of manufacture;(2) lack of adequate structural support for commissures; and (3) lack ofsuitable geometry for properly anchoring a valve component.

Thus, a need exists for an improved prosthetic valve device, an improvedvalve component, and/or an improved frame, including methods of formingthe same.

SUMMARY

In certain aspects, the present invention is directed to a prostheticvalve device that is suitable for implantation in a body lumen, andcomponents thereof, such as the valve component and the frame. In otheraspects, the invention is directed to methods of forming a prostheticvalve device, the valve component and/or the frame.

In some embodiments, the invention provides a prosthetic valve devicefor implantation into a body lumen comprising: a frame comprising atubular body; and a valve component disposed within the tubular body ofthe frame, the valve component comprising: an annular sleeve forming afluid passageway along an axis from a fluid inlet to a fluid outlet; anda plurality of commissures forming a plurality of collapsible leafletsat the fluid outlet for opening and sealing the fluid passageway, eachof the commissures anchored to the tubular body of the frame and formedby a cinched portion of the annular sleeve located between opposing legsof a commissure strip.

In other embodiments, the invention provides a valve component to beanchored within a frame for implantation into a body lumen, the valvecomponent comprising: an annular sleeve forming a fluid passageway alongan axis from an inlet edge to an outlet edge; and a plurality ofcommissure strips arranged in a spaced-apart arrangement about acircumference of the outlet edge, each of the commissure strips affixedto and cinching a portion of the annular sleeve between opposing legs ofthe commissure strip.

In further embodiments, the invention provides a method of forming aprosthetic valve device for implantation into a body lumen comprising:a) forming a valve component by: a1) forming an annular sleeve having afluid passageway along an axis from an inlet edge to an outlet edge; anda2) affixing a plurality of commissure strips in a spaced-apartarrangement about a circumference of the outlet edge, each of thecommissure strips cinching a portion of the annular sleeve betweenopposing legs of the commissure strip to form a commissure; and b)providing a frame having a tubular body; c) positioning the valvecomponent within the tubular body of the frame; and d) anchoring thecommissures to the tubular body of the frame to form a plurality ofcollapsible leaflets at the outlet edge for opening and sealing thefluid passageway.

Still further embodiments provide a method of forming a valve componentfor a prosthetic valve device comprising: forming an annular sleevehaving a fluid passageway along an axis from an inlet edge to an outletedge; and affixing a plurality of commissure strips in a spaced-apartarrangement about a circumference of the outlet edge, each of thecommissure strips cinching a portion of the annular sleeve betweenopposing legs of the commissure strip to form a commissure.

In yet other embodiments, the invention provides a prosthetic valvedevice for implantation into a body lumen comprising: a frame comprisinga tubular body; and a valve component disposed within and anchored tothe tubular body of the frame, the valve component comprising: anannular sleeve having an annular inner wall that forms a fluidpassageway along an axis from an inlet edge to an outlet edge, theannular sleeve folded over at the inlet edge to form an annular cuffthat is concentric to and surrounds the annular inner wall and extendsfrom the inlet edge toward the outlet edge; and an annular beltpositioned between the annular inner wall and the annular cuff andhaving a bottom edge adjacent to a bight portion of the annular sleevethat forms the inlet edge.

Some embodiments provide a valve component to be anchored within a framefor implantation into a body lumen, the valve component comprising: anannular sleeve having an annular inner wall that forms a fluidpassageway along an axis from an inlet edge to an outlet edge, theannular sleeve folded over at the inlet edge to form an annular cuffthat is concentric to and surrounds the annular inner wall and extendsfrom the inlet edge toward the outlet edge; and an annular beltpositioned between the annular inner wall and the annular cuff andhaving a bottom edge adjacent to a bight portion of the annular sleevethat forms the inlet edge.

In still further embodiments, the invention provides a method of forminga prosthetic valve device for implantation into a body lumen comprising:a) forming an annular sleeve; b) affixing an annular belt to the annularsleeve, the annular belt having a bottom edge; c) providing a framehaving a tubular body; d) anchoring the annular sleeve and the annularbelt within the tubular body of the frame; and e) folding the annularsleeve inward upon itself along the bottom edge of the annular belt soas to form an annular inner wall and an annular cuff that is concentricto and surrounds the annular inner wall, the annular inner wall forminga fluid passageway along an axis from an inlet edge to an outlet edge,the bottom edge of the annular belt adjacent to a bight portion of theannular sleeve that forms the inlet edge.

Other embodiments provide a method of forming a valve component for aprosthetic valve device for implantation into a body lumen comprising:a) forming an annular sleeve; b) affixing an annular belt to the annularsleeve, the annular belt having a bottom edge; c) folding the annularsleeve along the bottom edge of the annular belt so as to form anannular inner wall and an annular cuff that is concentric to andsurrounds the annular inner wall, the annular inner wall forming a fluidpassageway along an axis from an inlet edge to an outlet edge, whereinthe bottom edge of the annular belt is adjacent to a bight portion ofthe annular sleeve that forms the inlet edge.

In some embodiments, the invention provides a prosthetic valve devicefor implantation into a body lumen comprising: a frame comprising atubular body; and a valve component disposed within and anchored to thetubular body of the frame, the valve component comprising: an annularsleeve; an annular inner wall that forms a fluid passageway along anaxis from an inlet edge to an outlet edge; a plurality of commissuresarranged in a spaced-apart arrangement about a circumference of theoutlet edge of the annular inner wall, the commissures forming aplurality of collapsible leaflets for opening and sealing the fluidpassageway, the commissures anchored to the tubular body; and whereinwith the exception of the commissures, the annular inner wall is free ofanchoring penetrations.

Still further embodiments provide a prosthetic valve device forimplantation into a body lumen comprising: a frame comprising a tubularbody; a valve component disposed within and anchored to the tubular bodyof the frame, the valve component comprising: an annular sleeve formedfrom a single sheet of material, the annular sleeve comprising anannular inner wall that forms a fluid passageway along an axis from aninlet edge to an outlet edge, the annular sleeve folded over at theinlet edge to form an annular cuff that is concentric to and surroundsthe annular inner wall and extends from the inlet edge toward the outletedge; and a plurality of commissures arranged in a spaced-apart mannerabout a circumference of the outlet edge of the annular inner wall, thecommissures forming a plurality of collapsible leaflets for opening andsealing the fluid passageway, the commissures anchored to the tubularbody.

In yet other embodiments, the invention provides a prosthetic valvedevice for implantation into a body lumen comprising: a frame comprisinga tubular body; and a valve component disposed within and anchored tothe tubular body of the frame, the valve component comprising: anannular sleeve comprising an annular inner wall that forms a fluidpassageway along an axis from a fluid inlet to a fluid outlet; aplurality of commissures arranged in a spaced-apart manner about acircumference of the fluid outlet and anchored to the tubular body, thecommissures forming a plurality of collapsible leaflets for opening andsealing the fluid passageway, wherein the fluid outlet has a firstdiameter and the fluid inlet has a second diameter that is greater thanthe first diameter; and wherein the fluid inlet forms a lower plane of areference truncated cone and the fluid outlet forms an upper plane ofthe reference truncated cone, the reference truncated cone having aheight and being a portion of a 9° to 11° cone, wherein a ratio of thesecond diameter to the height is in a range of 1.3:1 to 1.5:1.

Yet other embodiments provide a blank for forming a valve component of aprosthetic valve device for implantation into a body lumen, the blankcomprising: a single sheet of pliable material comprising a leafletsection comprising an arcuate top edge, an arcuate bottom edge, andlinear left and right side edges extending between the arcuate top andbottom edges; the arcuate top and bottom edge extending substantiallyparallel to one another and the left and right side edges extending atan angle between 31° to 33° with respect to one another.

In still other embodiments, the invention provides a method of forming atubular body of a frame for a prosthetic valve device comprising: a)cutting a pattern into a tube having a first inner diameter and an axis,the pattern comprising a plurality of post pattern sections arranged onthe tube in a circumferentially spaced-apart manner and a plurality oflattice pattern sections extending between the post pattern sections;and b) diametrically expanding the tube until the tube has a secondinner diameter that is greater than the first inner diameter, whereinthe expanded tube comprises a plurality of axial posts arranged on theexpanded tube in a circumferentially spaced-apart manner and a pluralityof lattices having open cells extending between the axial posts.

In yet other embodiments, the invention provides a frame for aprosthetic valve device comprising a tubular body comprising an axis, aplurality of circumferentially spaced-apart axial posts and a latticestructure comprising open cells extending between each of the axialposts, and wherein the lattice structures and the axial posts areintegrally formed as a unitary structure free of seams.

In further embodiment, the invention provides a prosthetic valve devicefor implantation into a body lumen comprising: a frame comprising atubular body; a valve component comprising an annular sleeve having anannular inner wall that forms a fluid passageway along an axis from aninlet edge to an outlet edge, the annular sleeve folded over at theinlet edge to form an annular cuff that is concentric to and surroundsthe annular inner wall and extends from the inlet edge toward the outletedge; and wherein the valve component is disposed within and anchored tothe tubular body of the frame, the annular inner wall and the annularcuff positioned within the tubular body of the frame.

While the aforementioned inventions are particularly suited for use as(or in) a prosthetic heart valve, further areas of applicability of thepresent invention will become apparent from the detailed descriptionprovided hereinafter. It should be understood that the detaileddescription and specific examples, while indicating the preferredembodiments of the invention, are intended for purposes of illustrationonly and are not intended to limit the scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will become more fully understood from thedetailed description and the accompanying drawings, wherein:

FIG. 1 is a perspective view of a prosthetic valve device according tosome embodiments of the present invention;

FIG. 2 is a perspective view of the valve component of the prostheticvalve device removed from the frame, and in a closed state, according tosome embodiments of the present invention;

FIG. 3 is an exploded view of the valve component of FIG. 2;

FIG. 4 is a perspective view of the valve component of the prostheticvalve device removed from the frame, and in an open state, according tosome embodiments of the present invention;

FIG. 5 is a plan view of leaflet blank according to some embodiments ofthe present invention;

FIG. 6 is a plan view of the leaflet blank of FIG. 5 with a belt affixedthereto, according to some embodiments of the present invention;

FIG. 7 is a perspective of the leaflet blank of FIG. 6 formed into anannular sleeve, according to some embodiments of the present invention;

FIG. 8 is an axial cross-sectional schematic of the annular sleeve ofFIG. 7 positioned in axial alignment for anchoring to the frame of theprosthetic valve device of FIG. 1, according to some embodiments of thepresent invention;

FIG. 9 is an axial cross-sectional schematic of the annular sleeve ofFIG. 7 positioned within and anchored to the frame of the prostheticvalve device of FIG. 1, according to some embodiments of the presentinvention;

FIG. 10 is an axial cross-sectional schematic of the assembly of FIG. 8,wherein the annular sleeve has been folded-in on itself, and in whichcommissures have been created anchoring an outlet edge of the annularsleeve to the frame;

FIG. 11A is an axial cross-sectional schematic of one of the commissuresof the prosthetic valve device of FIG. 1 according to some embodimentsof the present invention;

FIG. 11B is a transverse cross-sectional schematic of one of thecommissures of the prosthetic valve device of FIG. 1 according to someembodiments of the present invention;

FIG. 12 is a 2-D rendering of a cutting pattern to be applied to a tubeto form a frame for a prosthetic valve device, according to someembodiments of the present invention;

FIG. 13 is a perspective view of a tube with a pattern of slits cut intothe tube in accordance with the cutting pattern of FIG. 12; and

FIG. 14 is a perspective view of the tube of FIG. 13 wherein the tubehas been diametrically expanded to form a frame according to someembodiments of the present invention.

DETAILED DESCRIPTION

The following description of the preferred embodiment(s) is merelyexemplary in nature and is in no way intended to limit the invention,its application, or uses.

Referring first to FIG. 1, a prosthetic valve device 1000 is illustratedaccording to some embodiments of the present invention. The prostheticvalve device 1000 can be used to replace, for example, a failed (e.g.,degenerated) aortic valve, mitral valve, or pulmonary cardiac valve(e.g., in a geriatric patient) in accordance with some embodiments ofthe present invention. Embodiments of the invention, however, are not solimited and the prosthetic valve device 1000 can be used in other bodylumens and/or in conjunction with other organs as desired. Theprosthetic valve device 1000 can be delivered to the implantation siteusing any suitable delivery approach, including “open-heart” delivery.However, the prosthetic valve device 1000 is particularly suited fortransluminal delivery, either in separate components or as a fullyassembled structure.

The prosthetic valve device 1000 generally comprises a valve component100 and a frame 200. The valve component 100 is disposed within andanchored to a frame 200. The frame 200, in the exemplified embodiment,is a stent component. In those embodiments of the present inventionwherein the prosthetic valve device 1000 is designed for transluminaldelivery, both the frame 200 and the valve component 100 are capable ofat least two configurations: a first, collapsed configuration (e.g.,during delivery) and a second, expanded configuration (e.g., afterimplantation). In FIG. 1, both the valve component 100 and the frame 200are in an expanded configuration. In the collapsed configuration, thevalve component 100 may remain disposed within the frame 200 so that theprosthetic valve device 1000 remains fully assembled prior to and/orduring transluminal delivery.

The frame 200 provides a sufficiently rigid structure so that the valvecomponent 100 can be anchored thereto and is capable of maintaining itsdesired configuration. The frame 200 also provides the mechanism bywhich the prosthetic valve device 1000 is retained in the properposition and orientation at the desired implantation site. Theprosthetic valve device 1000 may be retained in the proper position andorientation at the desired implantation site by any known means known inthe art, none of which are to be considered limiting of the presentinvention unless specifically recited in the claims. For example, theframe 200 may be anchored directly to the inner wall of the body lumen(or to a secondary frame or stent in which the prosthetic valve device1000 is positioned). Such anchoring can be achieved, for example, viaknown techniques, including without limitation, suturing, stapling,puncturing, clamping or combinations thereof. In the exemplifiedembodiment, the frame 200 is a self-retaining structure that utilizesits tendency to diametrically expand to a diameter greater than thediameter of the body lumen at the implantation site, thereby creating acompression fit between the prosthetic valve device 1000 and the bodylumen to retain the prosthetic valve device 1000 in place at theimplantation site. The tendency of the frame 200 to diametrically expandcan be achieved by forming the frame 200 out of a shape memory material.In some embodiments, the frame 200 is formed of nickel titanium. Othershape memory materials can be utilized in other self-retainingembodiments. In embodiments wherein the frame 200 is not aself-retaining structure, the frame can be constructed of anybiocompatible material that is sufficiently rigid to provide therequired support to the valve component 100. Suitable alternatematerials include, without limitation, polymers, platinum, stainlesssteel, chonichrom, or combinations thereof.

The frame 200 comprises a tubular body 201 having an inner surface 202and an outer surface 203. The tubular body 200 comprises a central axis(which is coincident with the axis A-A of the fluid passageway of thevalve component 100). The tubular body 201 has a height H_(F) measuredfrom a bottom edge 204 of the tubular body 201 to a top edge 205 of thetubular body 201 along the axis A-A. The tubular body 201 furthercomprises an outer diameter D_(F).

In the exemplified embodiment, the frame 200 is of the self-retainingtype and thus, the outer diameter D_(F) is selected so as to be largerthan the diameter of the body lumen at implantation site. The heightH_(F), in one embodiment, is substantially equal to the outer diameterD_(F) when in the implanted state. In one specific embodiment in whichthe prosthetic valve device 1000 is designed for implantation to replacean aortic valve, the outer diameter D_(F) of the tubular body 201,pre-implant, is between 1 mm to 4 mm larger than the aortic annulus(which is the implantation site). In some embodiments, the aorticannulus is assumed to have a mean diameter of 22 mm in an elderlypopulation and, thus, the outer diameter D_(F) of the tubular body 201is between 23 mm to 24 mm. In this exemplary embodiment, the heightH_(F) was also selected to be between 20 mm to 22 mm, and specificallyapproximately 21 mm. The invention, however, is in no way limited to anyspecific dimensions of the frame 200, either empirical or relative,unless specifically recited in the claims.

As mentioned above, the frame 200, and thus the tubular body 201, issufficiently rigid and robust to withstand the forces resulting from thepressures imparted to the tubular body 201 by the valve component 100during pro-longed operation of the prosthetic valve device 1000, whilststill firmly anchored at the implantation site. Thus, in one embodimentof the frame 200 wherein the tubular body 201 is formed of nickeltitanium, the tubular body 201 has a thickness between 0.3 mm to 0.5 mm,with a thickness of 0.4 mm being selected in one specific embodiment. Inother embodiments, depending on such factors as the material ofconstruction of the tubular body 201, the dimensions of the tubular body201, and the parameters of the implantation site, the thickness of thetubular body 201 will be adjusted accordingly.

The inner surface 202 of the tubular body 201 forms a cavity 206 that isopen at both the top and bottom edges 204, 205, thereby forming an axialpassageway. When the prosthetic valve device 1000 is fully assembled,the valve component 100 is disposed within the cavity 206 and anchoredto the tubular body 201 (described in greater detail below).

In the exemplified embodiment, the tubular body 200 has a circulartransverse cross-sectional profile. However, in alternate embodiments,the transverse cross-sectional profile of the tubular body 201 can takeon other shapes. Noncircular transverse cross-sectional profiles may bedesirable in instances wherein the frame is to be positioned within anouter stent component.

The tubular body 201 of the frame 200 comprises a plurality of posts 207and a plurality of lattice structures 208 circumferentially extendingbetween and connected to the posts 207. The posts 207 extend from thebottom edge 204 to the top edge 205 of the tubular body 201 and, in theexemplified embodiment are substantially linear structures that aresubstantially parallel to the axis A-A. The posts 207 are arranged aboutthe circumference of the tubular body 201 in a spaced-apart manner. Morespecifically, the posts 207 are arranged in an equi-spaced manner aboutthe circumference of the tubular body 201. In certain embodiments, thenumber of posts 207 will correspond with the number of commissures 115present on the valve component 100 because the posts 207 providestructures within the tubular body 201 to which the commissures 115 aremounted. The tubular body 201 comprises a post 207 for each commissure115 of the valve component 100. The posts 207 are circumferentiallyarranged about the circumference of the tubular body 201 so as to beradially aligned with the commissures 115 of the valve component 100.

In the exemplified embodiment, there are three posts 207 because thevalve component 100 is a tricuspid type valve, thereby having threecommissures 115. However, in alternate embodiments, the tubular body 201can include more or less than three posts 207 as desired. Moreover, incertain embodiments, it is possible that the number of posts 207 can begreater than the number of commissures 115 of the valve component 100 inan effort to increase axial rigidity of the frame 200.

As mentioned above, the tubular body 201 of the frame comprises latticestructures 208 that extend between each of the posts 207. In theexemplified embodiment, the lattice structures 208 and the posts 207 areintegrally formed as a unitary structure free of seams. Thus, thetubular body 201 is a unitary structure. In some embodiments, thetubular body 200 may be made from wire or may be laser cut from a tube,sheath, or the like. One preferred method of forming the tubular body200 is described below with respect to FIGS. 12-14.

Referring now to FIGS. 1 and 8 concurrently, each of the latticestructures 208 comprise struts 209 that intersect at nodes 210. Thestruts 209 provide structures to which the valve component 100 can beanchored to the tubular body 201 of the frame 200. The nodes 210 arearranged in a plurality of circumferentially extending rows A-F that areaxially spaced from one another (see FIG. 8). The nodes 210 within eachcircumferential row A-F lie in the same transverse plane as other nodes210 within that same circumferential row A-F. These transverse referenceplanes are denoted as dotted lines P1-P6. As a result of theaforementioned geometrical arrangement of the rows of the nodes 210within the lattice structures 208, the struts 209 are also arranged incircumferential rows G-K, wherein the circumferential rows G-K of thestruts 209 are defined between the transverse planes A-F. In theexemplified embodiment, there are six circumferential rows A-F of nodes210 and five circumferential rows G-K of struts 209. In otherembodiments, more or less circumferential rows A-F of nodes 210 and/orcircumferential rows G-K of struts 209 can be used. The struts 209within each of the circumferential rows G-K are oriented so as to form asaw-tooth configuration. The aforementioned configuration of the latticestructures 208 of the tubular body 201 is used to anchor the valvecomponent 100 within the frame 200 in a manner that prevents both axialand circumferential slippage of the valve component 100 during operationof the prosthetic valve device 1000.

The lattice structures 208 further comprise a plurality of open cells211 formed by the struts 210. In the exemplified embodiment, all of theopen cells 211 within all of the lattice structures 208 are adiamond-shape or a partial diamond-shape. The invention, however, is notso limited in all embodiments.

Referring now to FIGS. 1-4 and 10 concurrently, the valve component 100will be discussed in greater detail. The valve component 100 comprises afluid passageway 101 having an axis A-A through which a bodily fluid canflow. The valve component 100 is the working component of the prostheticvalve device 1000 and is alterable between: (1) an open state, shown inFIG. 4, in which the fluid passageway 101 is open and allows a bodyfluid to pass therethrough from the fluid inlet 102 to the fluid outlet103; and (2) a sealed state, shown in FIG. 2, in which the fluidpassageway 101 is sealed and prevents backflow of bodily fluid that hasexited the fluid outlet 103. The valve component 100 is disposed withinand anchored to the tubular body 201 of the frame 200 so as to becapable of repetitively alternating between the open and closed stateswhen the prosthetic valve device 1000 is anchored at the implantationsite.

The valve component 100 generally comprises an annular sleeve 104, anannular belt 105 and a plurality of commissure strips 106. Each of theannular sleeve 104, the annular belt 105 and the plurality of commissurestrips 106 are preferably formed of a pliable material. In someembodiments, each of the annular sleeve 104, the annular belt 105 andthe plurality of commissure strips 106 are formed of the same material.However, in alternate embodiments, the annular sleeve 104, the annularbelt 105 or the plurality of commissure strips 106 may be formed ofdifferent pliable or non-pliable materials with respect to one or bothof the others. Suitable materials for construction of the annular sleeve104, the annular belt 105 and/or the plurality of commissure strips 106include, without limitation, biological tissues and biocompatiblepolymers. Suitable biological tissues may include tissues that are humanand/or porcine in nature. In one specific embodiment, the annular sleeve104, the annular belt 105 and the plurality of commissure strips 106 areformed of porcine pericardium tissue that is suitably treated forbiocompatibility and/or to prevent decay. Suitable biocompatiblepolymers include, without limitation, polyurethane, silicones, orcombinations thereof.

The annular sleeve 104 generally comprises an annular inner wall 107 andan annular cuff 108 (described in greater detail below). The valvecomponent 100 extends from an inlet edge 109 to an outlet edge 110 whenassembled for use in the prosthetic valve device 1000. The inlet edge109 defines the fluid inlet 102, which in the exemplified embodiment isan opening lying within a transverse plane. The outlet edge 110 definesthe fluid outlet 103, which in the exemplified embodiment is an openinglying within a transverse plane. The annular sleeve 104 comprises boththe inlet edge 109 and the outlet edge 110. The annular inner wall 107of the annular sleeve 104 extends from the inlet edge 109 to the outletedge 110 and defines the fluid passageway 101 that extends between thefluid inlet 102 and the fluid outlet 103. The annular inner wall 107 ofthe annular sleeve 104 extends a height H_(S) measured along the axisA-A from the fluid inlet 102 to the fluid outlet 103. Conceptually, theheight H_(S) can also be considered as defining the height of theannular sleeve 104 when the valve component 100 is fully formed, or theheight of the fluid passageway 101.

In the exemplified embodiment, the annular inner wall 107 of the annularsleeve 104 defines the fluid passageway 101. More specifically, theinner surface 111 of the annular inner wall 107 forms the fluidpassageway 101. The fluid passageway 101 extends along the axis A-A andforms a conduit through the cavity 206 of the tubular body 201 of theframe when the prosthetic valve device 1000 is assembled.

The valve component 100 comprises a plurality of commissures 115arranged about the circumference of the outlet edge 110 in aspaced-apart manner. As discussed in greater detail below, thecommissures 115 are anchored to the tubular body 201 of the frame 200.The commissures 115 are equi-spaced from one another about thecircumference of the outlet edge 110. In the exemplified embodiment,three commissures 115 are provided and are arranged approximately 120°apart about the circumference of the outlet edge 110. In alternateembodiments, more or less than three commissures 115 can be formed.

During operation of the prosthetic valve device 1000 at the implantationsite, the commissures 115 act as anchoring points for the annular innerwall 107 along the outlet edge 110. Because the annular sleeve 104 (andthus the annular inner wall 107) is formed of a pliable material, thecommissures 115 form a plurality of collapsible leaflets 112-114therebetween. The collapsible leaflets 112-114 are circumferentialsections of the annular inner wall 107 of the annular sleeve 104. One ofthe commissures 115 is located between each pair of adjacent collapsibleleaflets 112-114. The collapsible leaflets 112-114 collectively form thefluid outlet 103 (during the open-state of the valve component 100).During the pumping of bodily fluid through the fluid passageway 101(from the fluid inlet 102 to the fluid outlet 103), the collapsibleleaflets 112-114 are deflected from their closed-state (FIG. 2) to theiropen-state (FIG. 4), thereby allowing the bodily fluid to flow throughthe fluid passageway 101 and out of the prosthetic valve device 1000.Once pressure on the fluid inlet 102 is ceased, the collapsible leaflets112-114 collapse in upon themselves and transition from their open-state(FIG. 4) to their closed-state (FIG. 2), thereby prohibiting bodilyfluid that has exited the fluid outlet 103 from back-flowing into thefluid passageway 101.

Referring now to FIGS. 1-3 and 11A-B concurrently, the commissures 115are formed by commissure strips 106 that are affixed to the outlet edge110 of the annular inner wall 107 at the desired circumferentiallocation. Thus, similar to the commissures 115, the commissure strips106 are arranged about the circumference of the outlet edge 110 in anequi-spaced circumferential manner. In the exemplified embodiment, eachof the commissures 115 is formed by cinching a portion 116 of theannular inner wall 107 of the annular sleeve 104 between opposing legs117A-B of one of the commissure strips 106. In the exemplifiedembodiment, each commissure strip 106 is an elongated strip of materialthat is folded over the outlet edge 110 of the cinched portion 116,thereby forming a general U-shape (best shown in FIG. 11A). Thus, insuch an embodiment, each commissure strip 106 comprises the opposinglegs 117A-B and a bight portion 118. However, in alternate embodiments,each of the opposing legs 117A-B of the commissure strips 106 can beformed by two separate strips of material that are positioned onopposing sides of the cinched portion 116 and affixed thereto. Incertain other alternate embodiments, the commissure strips 106 can beformed out of a properly dimensioned portions of the annular sleeve 104itself, rather than as separate components.

Once the cinched portions 116 of the annular inner wall 107 are disposedbetween the opposing legs 117A-B of the commissure strips 106, thecommisure strips 106 are affixed to the annular inner wall 107 of theannular sleeve 104. When so positioned, both of the opposing legs 117A-Bof each commissure strip 106 are adjacent to an outer surface 119 of theannular inner wall 107 at the cinched portion 116. More specifically, asexemplified, the inner surfaces 121 of the opposing legs 117A-B of thecommissure strips 106 are in surface contact with the outer surface 119of the annular inner wall 107 at the cinched portions 116.

For each commissure 115, the opposing legs 117A-B of the commissurestrip 106 and the cinched portion 116 of the annular inner wall 107collectively form a multi-layer structure 120. In the exemplifiedembodiment, each multi-layer structure 120 includes four layers, a firstlayer formed by the leg 117A of the commissure strip 106, second andthird layers formed by the cinched portion 116 of the annular inner wall107 of the annular sleeve 104, and a fourth layer formed by the leg 117Bof the commissure strip 106. At least one fastening element 122penetrates through each layer of the multi-layer structure 120 so as toaffix the opposing legs 117A-B of the commissure strip 106 and thecinched portion 116 of the annular inner wall 107 together. As usedherein, the terms “fastening element” and “fasteners” areinterchangeable. In the exemplified embodiment, the fastening element122 is a single suture. However, in alternate embodiments, the fasteningelement 122 can be multiple sutures, or can be other structures such asstaples, adhesives, barbs, clamps or combinations thereof.

The suture 122, in the exemplified embodiment, comprises free ends 123,124 that extend from the opposing sides of the commissure 115. Duringassembly of the prosthetic valve device 1000, these free ends 123, 124are used to anchor the commissure 115 to the tubular body 201 of theframe. For example, in one embodiment, for each commissure 115, the freeends 123, 124 of each suture 122 are wrapped around the axial post 207of the frame 200 with which that commissure 115 is radially aligned. Foreach commisure 115, the commisure strip 106 is affixed to the cinchedportion 116 so that a cusp portion 125 protrudes radially outward fromthe commissure strip 106. The cusp portions 125 are anchored to thetubular body 201 of the frame 200 to anchor the commisures 115 in place.In the exemplified embodiment, each of the cusp portions 125 is anchoredto a corresponding axial post 207 of the tubular body 201 that is inradial alignment with that commissure 115. The anchoring of each cuspportion 125 is achieved by a plurality of sutures 126 that wrap aroundthe axial post 207 so as to retain both the axial and circumferentialposition of the corresponding commissure 115 with respect to the frame200. When the valve component 100 is anchored to the frame 200 to formthe prosthetic valve device 1000 (as shown in FIG. 1), the cusp portions125 are located radially inward of the tubular body 201 of the frame200. In other embodiments, the cusp portions 125 can be anchoredutilizing different fasteners, such as staples, adhesives, clamps,barbs, or combinations thereof.

As a result of using the commissure strips 106, the commissures 115 areformed as post-like structures. Moreover, in one specific embodiment,because the commissures 115 are formed entirely out of the pliablematerial (which in the exemplified embodiment is the cinched portion 116and the commissures strips 106), the commissures 115 allow for somemovement, similar to those in the native aortic valve.

Moreover as will be described in greater detail below, the annularsleeve 104, in certain embodiments, will be formed by a single rolledsheet of material having a single axial seam 127 (FIG. 7). In such anembodiment, when the annular sleeve 104 is formed to create the annularinner wall 107, this single axial seam 127 can be located within one ofthe cusp portions 125. Locating the axial seam 107 within one of thecusp portions 125 prevents the axial seam 127 from being located on, andpotentially affecting the operation of, the leaflets 112-114. Inembodiments wherein the annular sleeve 104 (and thus the annular innerwall 107) are formed by multiple sheets of material connected togethervia multiple axial seams 127, it may be preferred that all of such axialseams 127 be located within the cusp portions 125. The invention,however, is not so limited in all embodiments. In some embodiments, thesutures used herein are a 4-0 Ethicon nylon black monofilament, forexample, in certain embodiments. Other sutures may also be used. Forexample, one other suture type is 5-0 Ethibond.

Utilization of the commissure strips 106 to form the commissures 115allows the leaflets 112-114 to be formed free of both affixing andanchoring penetrations. All such affixing and anchoring penetrations inthe upper portion of the annular inner wall 107 are located within thecommissures 115, and specifically within the commissure strips 106, thecinched portions 116, and/or the cusp portions 125. Thus, the commissurestrips 106 help protect the valve component 100 from failure/fatigue atthe aforementioned affixing and anchoring penetrations by isolating themfrom the working motion of the collapsible leaflets 112-114. It shouldbe noted that in certain embodiments, the commissures 115 can be formedin a different manner than utilizing the commissure strips 106.

Further, the commissure strips 106 themselves are designed to preventdamage to the collapsible leaflets 112-114. Specifically, each of theopposing legs 117A-B of the commissure strips 106 comprises an inneredge 128. Each of the inner edges 128 have a bottom portion 129 thattapers radially outward. Preferably, all corners of the opposing legs117A-B of each commissure strip 106 are rounded.

Referring to FIGS. 10 and 11 concurrently, when the commissure strips106 are affixed to the annular inner wall 107, the opposing legs 117A-Bof each commissure strip 106 extend an axial distance D_(S) from theoutlet edge 110 toward the inlet edge 109 of the annular inner wall 107.The axial distance D_(S) is less than the axial height H_(S) of theannular inner wall 107, which is measured from the inlet edge 109 to theoutlet edge 110 along the axis A-A. In certain embodiments, the axialdistance D_(S) is 30% to 55% of the axial height H_(S). In one specificembodiment, the axial distance D_(S) is between 5 to 7 mm, and morepreferably approximately 6 mm. The axial height H_(S), in such anembodiment, can be between 13 to 15 mm, and more preferablyapproximately 14 mm.

Referring solely now to FIGS. 4 and 10 concurrently, optimization of thedesign of the valve component 100, in one embodiment of the invention,will be discussed. FIG. 10 is an axial cross-sectional view of the fullyassembled prosthetic valve device 1000 of FIG. 1, in the open-state. Thevalve component 100 is disposed within the cavity 206 of the frame 200and anchored to the tubular body 201 of the frame 200 (the anchoring ofwhich was partially discussed above and will be described in greaterdetail below). The dimensions of the valve component 100 (and especiallythe annular sleeve 104 and/or the commissures 115) are optimized so thatthe leaflets 112-114 achieve: (1) no leakage of the bodily fluid throughthe fluid passageway 101 when the leaflets 112-114 are in theclosed-state (FIG. 2); (2) synchronous closure of the leaflets 112-114;(3) symmetric closure of the leaflets 112-114; and (4) minimization orelimination of folds in the leaflets 112-114 (in both the open-state andclosed-state).

As mentioned above, the inner surface 111 of the annular inner wall 107defines the fluid passageway 101 which extends along the axis A-A. Thefluid inlet 102, which is defined by the inlet edge 109, conceptuallydefines an opening having a second diameter D₂ and that lies within atransverse plane P_(I) (visible as a line in FIG. 10). Similarly, thefluid outlet 103, which is defined by the outlet edge 110 (excluding thecinched portions 116), conceptually defines an opening having a firstdiameter D₁ and that lies within a transverse plane P_(O) (visible as aline in FIG. 10). The second diameter D₂ is greater than the firstdiameter D₁. In some embodiments, the annular sleeve 104 is dimensionedso that the second diameter D₂ is in a range of 19 to 21 mm, with 20.25mm being preferred in one specific embodiment, while the first diameterD₁ is in a range of 15 to 17 mm, with 16.25 mm being preferred in onespecific embodiment. The invention, however, is not limited to anyspecific measurements unless specifically recited in the claims.Moreover, as will become apparent from the discussion below, theempirical numbers of the optimization dimensions is not as important asthe relativity between said dimensions, which can be scaled up or downas necessary.

The transverse plane P_(I) is substantially parallel to the transverseplane P_(O) in the exemplified embodiment, and separated by the heightH_(S) (which can also be considered the height of the annular inner wall107 and the length of the fluid passageway 101). Conceptually, the fluidinlet 102 and the fluid outlet 103 can be considered to form a referencetruncated cone C_(R), wherein the fluid inlet 102 forms the delimitinglower plane of the reference truncated cone C_(R) while the fluid outlet103 forms the delimiting upper plane of the reference truncated coneC_(R). In FIG. 10, the reference truncated cone C_(R) has a central axisthat is coincident with the axis A-A, and is simply illustrated as thedotted lines C_(R) due to the plan-nature of FIG. 10. The referencetruncated cone C_(R) is a portion of cone having an angle Θ. In certainembodiments, the angle Θ is in a range of 9° to 11°, and in one specificembodiment, the angle Θ is approximately 10°.

Furthermore, it has been discovered that, in certain embodiments of theinvention, optimal performance of the valve component 100 is achievedwhen: (1) the angle Θ is in a range of 9° to 11°; and (2) the seconddiameter D₂ and the height H_(S) are selected so that the ratio of thesecond diameter D₂ to the height H_(S) is in a range of 1.3:1 to 1.5:1.In one specific embodiment, optimal performance of the valve component100 is achieved when: (1) the angle θ is approximately 10°; and (2) theratio of the second diameter D₂ to the height H_(S) is approximately1.4:1. Utilizing the preferred angle θ and the preferred ratio of thesecond diameter D₂ to the height H_(S) allow the valve component 100 tobe scaled up or down as desires while still achieving optimalperformance. The frame 200 can similarly be scaled up or down in acorresponding manner to accommodate the scale of the valve component100.

Referring now to FIGS. 3 and 10 concurrently, the structure of the valvecomponent 100 will be further discussed in relation to the annular belt105 and the annular cuff 108. The annular sleeve 104 comprises theannular inner wall 107 and the annular cuff 108. In the exemplifiedembodiment, the annular sleeve 104 is formed from single sheet ofmaterial and, thus, the annular inner wall 107 and the annular cuff 108are also integral with one another. However, in alternate embodiments,it is possible that the annular inner wall 107 and the annular cuff 108can be separate sheets of material that are coupled together.

The annular cuff 108 and annular inner wall 107 are formed by foldingthe annular sleeve 104 over at the inlet edge 109, thereby forming abight portion 130. Thus, the bight portion 130 comprises (or forms) theinlet edge 109 and can conceptually considered as defining the fluidinlet 102. The annular cuff 108 is concentric to and circumferentiallysurrounds the annular inner wall 107. In the exemplified embodiment,both the annular cuff 108 and the annular inner wall 107 are generallyconcentric to the axis A-A. Further, in the exemplified embodiment, theannular cuff 108 is a single continuous ring-like element. It ispossible, in certain alternate embodiments, that the annular cuff 108can be formed by a collection of non-continuous segments.

The annular cuff 108 extends axially from the inlet edge 109 toward theoutlet edge 110, terminating at a top edge 131. As discussed in greaterdetail below, the top edge 131 of the annular cuff 108 is anchored tothe tubular body 201 of the frame 200. In the exemplified embodiment,the top edge 131 is located below the top edge 205 of the tubular body201 of the frame 200 when the prosthetic valve device 1000 is assembled.The top edge 131 of the annular cuff 108 is saw-toothed in theexemplified embodiment. The saw-tooth pattern of the top edge 131 isconfigured to correspond to the lattice structures 208 of the tubularbody 201 of the frame 200 so as to facilitate anchoring thereto. Morespecifically, the saw-tooth pattern of the top edge 131 is configured tocorrespond to the configuration of the struts 209 of the latticestructures 208 that make up the circumferential row J (FIG. 8). Once thesaw-toothed top edge 131 of the annular cuff 208 is aligned with thestruts 209 of the lattice structures 208 of circumferential row J (asshown in FIG. 1), the saw-toothed top edge 131 is anchored thereto viafasteners, such as the sutures 132 (which are all located incircumferential row J). In other embodiments, the anchoring of the topedge 131 of the annular cuff 208 can be achieved via staples, barbs,clamps, adhesives, fusing, or combinations thereof. Furthermore, inalternate embodiments, the top edge 131 may take on a configurationother than saw-tooth, such as linear, contoured, sine-wave, irregularshape, or combinations thereof.

The annular belt 105 is formed of a single widened strip of sheetmaterial that is concentric to and circumferentially surrounds theannular inner wall 107. The annular belt 105 is positioned between theannular cuff 108 and the annular inner wall 107. The annular cuff 108 ispositioned so that a bottom edge 133 of the annular cuff 108 is adjacentto the bight portion 130 of the annular sleeve 104. During operation ofthe valve component 100 during implantation, the bottom edge 133 of theannular cuff 108 acts as a circumferential barrier that preventsstresses and strains experienced by the annular inner wall 107 (due tofluid flow and movement of the collapsible leaflets 112-114) from beingimparted to the anchoring penetrations in the annular sleeve 104resulting from the fasteners 134 that anchor the inlet portion of thevalve component 100 to the tubular body 201 of the frame 200. In theexemplified embodiment, the fasteners are 134 are sutures. Asexemplified, the sutures 134 are run in a saw-tooth configuration alongthe struts 209 of circumferential row H. In other embodiments, theanchoring of the inlet portion of the valve component 100 can beachieved via staples, barbs, clamps, adhesives, fusing, or combinationsthereof.

Referring now to FIGS. 1 and 10 concurrently, the annular belt 105 isaffixed to the annular sleeve 104 only along the annular cuff 108. As aresult, there are no penetrations in the annular inner wall 107resulting from the attachment of the annular belt 105 to the annularsleeve 104. In the exemplified embodiment, the annular belt 105 iscircumferentially affixed to the annular cuff 108 at two axiallocations, the first of which is formed by the fasteners 134 and thesecond of which is formed by the fasteners 135. The fasteners 135, inthe exemplified embodiment are sutures, arranged in a straightcircumferential seam 136 (FIG. 6).

The fasteners 135 merely affix the annular belt 105 to the annular cuff108. The fasteners 134, however, are also used to anchor the inletportion of the valve component 100 to the tubular body 201 of the frame200. Thus, the inlet portion of the valve component 100 is anchored tothe tubular body 201 of the frame 200 by penetrating only the annularcuff 108 and the annular belt 105. Furthermore, because the outletportion of the valve component 100 is anchored to the tubular body 201of the frame 200 only by way of the commissures 115 (described above),the annular inner wall 107 is free of anchoring penetrations from theinlet edge 109 to the commissures 115 at the outlet edge 110. In fact,the only penetrations in the annular inner wall 107 between the inletedge 109 to the commissures 115 are the affixing penetrations thatextend axially due to the existence of the single axial seam 127 (FIG.7). However, these affixing penetrations present minimal risk offailure/wear due to their axial alignment and due to the fact that theyare not located within the moving collapsible leaflets 112-114.

Thought of another way, the top edge 131 of the annular cuff 108 isanchored to the tubular body 201 via fasteners 132 at a first axialdistance d₁ from a bottom edge 204 of the tubular body 201 of the frame200. The top portion of the annular belt 105 is affixed to the annularcuff 108 at a second axial distance d₂ via fasteners 135 from the bottomedge 204 of the tubular body 201 of the frame 200. The bottom portion ofthe annular belt 105 is affixed to the annular cuff 108 and anchored tothe tubular body 201 at a third axial distance d₃ via fasteners 134 fromthe bottom edge 204 of the tubular body 201 of the frame 200. The firstaxial distance d₁ is greater than the second axial distance d₂, and thesecond axial distance d₂ is greater than the third axial distance d₃.Isolation of the anchoring penetrations that anchor the inlet portion ofthe valve component 100 to the frame 200 from working stresses andstrains is accomplished, in part, by anchoring the inlet portion of theannular sleeve 204 using only the annular cuff and only at an axialdistance above the inlet edge 209.

In the exemplified embodiment, when the valve component 100 is anchoredwithin the tubular body 201 of the frame 200, the inlet edge 109 islocated at an axial location between the top edge 205 and the bottomedge 204 of the tubular body 201 of the frame 200. Thus, the annularcuff 108 is located within the tubular body 201 of the frame 200.However, in alternate embodiments, the annular cuff 108 may be foldedover the bottom edge 204 of the tubular body 201 of the frame 200,thereby resulting in the inner annular wall 107 being located inside ofthe tubular body 201 of the frame 200 while the annular cuff 108 islocated outside of the tubular body 201 of the frame 200. In suchembodiments, the annular belt 105 can be located inside or outside ofthe tubular body 201 of the frame 200. However, in such embodiments, theannular belt 105 will be axially positioned so that the bottom edge 133of the annular belt 105 extends beyond the bottom edge 204 of the frame200. Such an arrangement allows the bottom edge 133 of the annular belt105 to protect the annular sleeve 104 from being damaged by the bottomedge 204 of the frame 200 during operation and/or implantation.Moreover, positioning the annular cuff 108 outside of the tubular body201 may result in a better seal between the prosthetic valve component1000 and the walls of the body lumen at the implantation site.

As mentioned above, in the exemplified embodiment, the annular sleeve104 comprises both the annular inner wall 107 and the annular cuff 108.However, in alternate embodiments, the annular cuff 108 may be omittedand the annular sleeve 104 may simply comprise the annular inner wall107. In such alternate embodiments, the annular sleeve 104 itself wouldessentially take on the form of the annular inner wall 107 and form thefluid passageway 101 as discussed above.

Referring now to FIGS. 5-10, a method of forming the prosthetic valvedevice 1000 according to an embodiment of the present invention will bedescribed. Referring first to FIG. 5, a blank 300 having the exemplifieddimensions and geometry is cut (or otherwise formed) from a single sheetof pliable material, such as a sheet of natural tissue. Alternatematerials could include sheets of pliable biocompatible polymers thatcould be formed to size and shape in flexible sheets or cut later tosize and shape. The dimensions and geometry of the blank 300 areselected to achieve the optimal leaflet performance discussed.

The blank 300 generally comprises a leaflet section 301 and a cuffsection 302. When folded and formed into the valve component 100, theleaflet section 301 will form the annular inner wall 107 while the cuffsection 302 will form the annular cuff 208. The arcuate top edge 305will form the outlet edge 110. With respect to the leaflet section 301,sub-sections 301A-C will form the collapsible leaflets 112-114respectively. The leaflet section 301 is conceptually separated from thecuff section 302 by a fold line 303. The fold line 303 is the locationat which the annular sleeve 104 will be folded upon itself to form theannular inner wall 307 and the annular cuff 108. Thus, the fold line 303also demarcates the location at which the inlet edge 109 (and bightportion 130) will be formed in the formed valve component 100. Thus, thefold line 303 can also be considered a bottom edge 304 of the leafletsection 301. Furthermore, in embodiments where no annular cuff 308 isdesired, the cuff section 302 will be omitted and the bottom edge 304will delimit the blank 300.

Thus, the leaflet section 301 comprises an arcuate top edge 305, thebottom edge 304 (which is also arcuate), a left side edge 306 and aright side edge 307. The left and right side edges 306, 307 are linearand extend between the arcuate top and bottom edges 305, 304. Thearcuate top and bottom edges 305, 304 extend substantially parallel toone another while the left and right side edges 306, 307 extend at anangle β with respect to one another. In an embodiment of the blank 300that has been found to optimize leaflet 112-114 performance in theformed valve component 100, the angle β is selected to be between 31° to33°, and in a more specific embodiment the angle β is selected to beapproximately 32°.

The left and right side edges 306, 307 of the leaflet section 301 have alength L_(L). In the exemplified embodiment, the length L_(L) is equalto the height H_(S) (FIG. 10). In one embodiment, the length L_(L) is ina range of 13 to 15 mm, and in a more specific embodiment the lengthL_(L) is approximately 14 mm. The arcuate top edge 305 has a firstradius of curvature while the arcuate bottom edge 304 has a secondradius of curvature. In one embodiment, the first radius of curvature isin a range of 129 to 131 mm, and in a more specific embodiment the firstradius of curvature is approximately 130 mm. The second radius ofcurvature is in a range of 115 to 117 mm, and in a more specificembodiment the second radius of curvature is approximately 116 mm.

In an embodiment of the blank 300 that optimizes performance of theformed valve component 100, the length L_(L) and the second radius ofcurvature are selected so that the ratio of the second radius ofcurvature to the length L_(L) is in a range of 8.1 to 8.5, and in a morespecific embodiment a ratio of approximately 8.3.

The cuff section 302 extends from a bottom edge 308 to the fold line303. When the valve component 100 is formed, the bottom edge 308 of cuffsection 302 forms the top edge 131 of the annular cuff 108. In theexemplified embodiment, the bottom edge 308 is formed into the desiredsaw-tooth configuration of the top edge 131 of the annular cuff 108discussed above. The cuff section has a length L_(C). In one embodiment,the length L_(C) is in a range of 13 to 15 mm, and in a more specificembodiment the length L_(C) is approximately 14 mm. The left and rightside edges 309, 310 of the cuff section are co-linear with the left andright side edges 306, 307 of the leaflet section 301. The left sideedges 306, 309 of the leaflet section 301 and the cuff section 302collectively form a left side edge 313 of the blank 300. Similarly, theright side edges 307, 310 of the leaflet section 301 and the cuffsection 302 collectively form a right side edge 314 of the blank 300.

Immediately below the fold line 303, a suture boundary line 311 isillustrated. A suture free section 312 is formed between the fold line303 and the suture boundary line 311. The suture free section 312delineates the area of blank that is kept free of sutures or otherfasteners so that any anchoring penetrations in the to-be-formed annularsleeve 304 are spaced from the inlet edge 309 by a desired axialdistance, which is equal to distance a. In the exemplified embodiment,the distance a is approximately 1 mm.

Referring now to FIG. 6, once the blank 300 is formed as illustrated inFIG. 5, the annular belt 105, which is in the form of flat arcuate stripof sheet material, is properly positioned and affixed to the blank 300.More specifically, when the annular belt 105 is in flat strip form, thebottom edge 133 of the annular belt 105 is an arcuate edge having aradius of curvature that matches the first radius of curvature of thefold line 303 (which is also the bottom arcuate edge 304 of the leafletsection 301). The annular belt 105, when in flat strip form, alsocomprises an arcuate top edge 140 that is substantially parallel to thearcuate bottom edge 133.

The annular belt 105 can be formed by cutting a sheet of material, suchas natural tissue or a pliable polymeric sheet, to the proper geometryand dimensions. In certain other embodiments, the annular belt 105 canbe formed of a rigid or semi-rigid material, such as biocompatiblepolymers. In the exemplified embodiment, the annular belt 105 is aseparate and distinct component than the frame 200. Once formed, theannular belt 105, in flat strip form, is overlaid atop the blank 300 sothat the bottom edge 133 is substantially coextensive with the fold line303. The annular belt 105, in flat strip form, is then affixed to theblank 300 along the arcuate top edge via fasteners 135, which areexemplified as sutures, to form the seam 136. As can be seen in FIG. 6,the geometry and dimensions of the annular belt 105, in flat strip form,is substantially identical to the cuff section 302 of the blank 300 withthe exception of the saw-toothed edge portion.

Once the assembly of the blank 300 and the annular belt 105 (in flatstrip form) of FIG. 6 is created, the blank 300 is rolled about so thatthe side edges 313, 314 of the blank 300 are slightly overlapped, asshown in FIG. 7. Referring now to FIG. 7, once the blank 300 is rolledas described above, the overlapping edges 313, 314 are affixed together,thereby forming the annular sleeve 104, which at this point in theformation process is in the form of an elongated truncated cone 150having a single axial seam 127. The overlapping edges 313, 314 areaffixed together via fasteners, which in the exemplified embodiment aresutures. In other embodiments, however, the affixing may be accomplishedvia staples, clamps, adhesives, fusing, or combinations thereof.

Once the annular sleeve 104 (in truncated cone 150 form) is formed, theannular sleeve 104 is aligned with the frame 200 as shown in FIG. 8.Referring to FIG. 8, it can be seen that the annular belt 105 is locatedwithin the annular sleeve 104 (in truncated cone 150 form) at thisstage. The annular sleeve 104 (in truncated cone 150 form) is positionedso that the saw-toothed bottom edge 308 of the cuff section 302 (whichwill become the top edge 131 of the annular cuff 108) is closest to thetubular body 201 of the frame 200. The annular sleeve 104 (in truncatedcone 150 form) is then translated axially upward so that the cuffsection 302 enters the cavity 206 of the tubular body 201 of the frame200. This translation of the annular sleeve 104 (in truncated cone 150form) continues until the saw-toothed edge 308 of the cuff portion 302becomes aligned with the struts 209 within the circumferential row E, asshown in FIG. 9.

Referring now to FIG. 9, once the annular sleeve 104 (in truncated cone150 form) is so positioned the cuff section 302 of the annular sleeve104 (in truncated cone 150 form) is anchored to the tubular body 201 ofthe frame 200 by the fasteners 132. In the exemplified embodiment, thesaw-toothed bottom edge 308 is anchored to the tubular body 201 of theframe 200 by fasteners 132 that run in a saw-toothed configuration aboutthe circumference of the saw-toothed bottom edge 308, thereby anchoringthe saw-toothed bottom edge 308 to the struts 209 in the circumferentialrow E (see FIGS. 1 and 8). Of course, other types of fasteners, such asthe ones mentioned above, could be used and/or different types ofsuturing techniques, in other embodiments of the invention.

The cuff section 302 of the annular sleeve 104 (in truncated cone 150form) is further anchored to the tubular body 201 at a lower position(relative to the fasteners 132) of the frame via fasteners 134. In theexemplified embodiment, this additional anchoring is achieved byfasteners 134 that run in a saw-toothed configuration about thecircumference of the cuff section 302 of the annular sleeve 104 (intruncated cone 150 form), thereby anchoring the annular sleeve 104 (intruncated cone 150 form) to the struts 209 in the circumferential row H(see FIGS. 1 and 8). Of course, other types of fasteners, such as theones mentioned above, could be used and/or different types of suturingtechniques in other embodiments of the invention.

The annular sleeve 104 (in truncated cone 150 form) is then folded inupon itself by pushing the leaflet section 301 of the annular sleeve 104(in truncated cone 150 form) through the passageway 330 formed by thecuff section 301 (and the annular belt 105). This motion isschematically exemplified by the arrows F in FIG. 9.

Prior to the aforementioned folding (or subsequent thereto if desired),the commissures 115 (FIG. 2) are formed into the edge 305, 110. Thecommissures 115 are formed in a spaced-apart arrangement about thecircumference of the edge 305, 110 as discussed above. This isaccomplished by cinching portions 116 of the annular sleeve 104, 150between opposing legs 117A-B of the commissure strips 106 and affixingthe commissure strips 106 to the cinched portions 116 in the desiredspaced-apart circumferential arrangement discussed above.

Once the annular sleeve 104, 150 is folded in on itself and thecommissures 115 are formed therein as described above, the commissures115 are anchored to the axial posts 207 of the tubular body 201 of theframe 200 as described above, thereby forming the prosthetic valvedevice 1000. The final arrangement is shown in FIGS. 1 and 10.

Referring now to FIGS. 12-14, a method of forming a tubular body of aframe for a prosthetic valve device, and the resulting frame, will bedescribed in accordance with an embodiment of the present invention.

A 2-D rendering of a cutting pattern 400 according to an embodiment ofthe present invention is illustrated in FIG. 12. The cutting pattern 400is designed to be applied to 3-D tube 500A (FIG. 13) of memory shapematerial and then cut into the 3-D tube 500A as will be described ingreater detail below. The 2-D pattern 400 is configured to include aplurality of post pattern sections 401 and a plurality of latticepattern sections 402 that extend between the post pattern sections 401.In the exemplified embodiment, the cutting pattern 400 comprises threepost pattern section 401 and the lattice pattern sections 402 (theleft-most and right-most sections of lattice pattern sections 402 beingconsidered a single section 402). As will be described in greater detailbelow, the post pattern sections 401 are designed to form the axialposts 207A in the tubular frame 201A of the resulting frame 200A (FIG.14) while the lattice pattern sections 401 are designed to form thelattice structures 208A in the tubular frame 201A of the resulting frame200A.

As can be seen, the cutting pattern 400 is formed entirely of linearslits 403-406, which in the exemplified embodiment, all extendsubstantially parallel to one another and vertically. Thus, when thecutting pattern 400 is applied to the 3-D tube 500A, all of the slits403-406 extend substantially parallel to the axis A-A of the tube 500(shown in FIG. 13).

All of the linear slits 403-406 of the cutting pattern 400 are arrangedin vertical columns (which become axial columns when applied to the 3-Dtube 500A). In the exemplified embodiment, there are only four differentlengths of slits used to create the entire cutting pattern 400. Eachcolumn 408 of slits in the lattice pattern sections 402 are formed bytwo longer slits 403 and one shorter slit 404. The columns 408 of thelattice pattern sections 402 are arranged in an offset alternatingmanner due to the fact that the positioning of the shorter slit 403 inadjacent columns 408 alternates between the top edge and the bottomedge. Each of the post pattern sections 401 are formed by a singlecolumn 409 of two longer slits 405 and a short slit 406.

Adjacent slits 403, 404 in the same columns 408 of the lattice patternsections 402 are separated by gaps 410 having a first vertical distancex₁ (which can be considered a first axial distance when applied to the3-D tube 500A). Similarly, adjacent slits 405, 406 in the same columns409 of the post pattern sections 401 are separated by gaps 411 having asecond vertical distance x₂ (which can be considered a second axialdistance when applied to the 3-D tube 500A). Because the second axialdistance x₂ is greater than the first axial distance x₁, a cleardistinction between the post pattern sections 401 and the latticepattern sections 402 is visible within the cutting pattern 400. In oneembodiment, the second axial distance x₂ is 4 to 5 times greater thanthe first axial distance x₁.

As will become apparent from the discussion below, when the frame 200Ais formed using the cutting pattern 400 as described below, the gaps 410of the lattice pattern sections 402 form nodes 210A within the latticestructures 208A of the tubular body 201A of the frame 200A while thegaps 411 of the post pattern sections 401 form axially elongated nodes212A within the axial posts 207A.

Referring now to FIG. 13, once the 2-D rendering of the cutting pattern400 is generated, it is applied to a 3-D tube 500A of a shape memorymaterial, such as nickel titanium. Of course other shape memorymaterials can be used. The 3-D tube 500A has a first inner diameterD_(T). The cutting pattern 400 is applied to the 3-D tube 500A so as tocircumferentially surround the 3-D tube in a uniform manner. The cuttingpattern 400 is applied to the 3-D tube 500A, in one embodiment, by lasercutting the slits 403-405 through the thickness of the 3-D tube 500A inthe illustrated pattern. Of course, other cutting or formationtechniques can be utilized as desired.

Once the cutting pattern 400 has been applied to the 3-D tube 500A, the3-D tube 500A is diametrically expanded until it has a second innerdiameter D_(E), thereby becoming an expanded 3-D tube 500B, which is thetubular body 201A of the frame 200A (FIG. 14). The second inner diameterD_(E) is greater than the first inner diameter D_(T). In one embodiment,the first and second inner diameters D_(T), D_(E) are selected so that aratio of the second inner diameter D_(E) to the first inner diameterD_(T) is in a range of 4:1 to 6:1. Methods and techniques fordiametrically expanding the 3-D tube 500A into the expanded 3-D tube500B utilizing mandrels and heating techniques are known in the art andrequire no further discussion herein.

Referring now to FIGS. 12-14 concurrently, as a result of the diametricexpansion of the 3-D tube 500A, the slits 403-406 of the applied cuttingpattern 400 are circumferentially stretched to form open cells 211A inthe lattice structures 208A and open cells 215A in the axial posts 207A.More specifically, the slits 405, 406 of the post pattern sections 401are transformed into the open cells 415A while the slits 403, 404 of thelattice pattern sections 402 are transformed into the open cells 411A.Further, the gaps 410 of the lattice pattern sections 402 aretransformed into the nodes 210A within the lattice structures 208A whilethe gaps 411 of the post pattern sections 401 are transformed into theaxially elongated nodes 212A within the axial posts 207A.

The expanded tube 500B (which is the tubular body 201A of the frame200A), comprises a plurality of the axial posts 207A arranged about theexpanded tube 500B in a circumferetially spaced-apart manner and aplurality of the lattice structures 208A which comprise the open cells211A therein extending between the axial posts 207A. Because the frame200A is formed by a single tube, the lattice structures 208A and theaxial posts 207A are integrally formed as a unitary structure free ofseams. All of the open cells 211A of the lattice structures 208A are ofa diamond-shape or a partial diamond-shape.

Further, it is to be understood that the frame 200A can be utilized toform the prosthetic valve device 1000 interchangeably with frame 200.Thus, the discussion of the frame 200 and its interaction with the valvecomponent 100 is also applicable to the frame 200A.

As used throughout, ranges are used as shorthand for describing each andevery value that is within the range. Any value within the range can beselected as the terminus of the range. In addition, all references citedherein are hereby incorporated by referenced in their entireties. In theevent of a conflict in a definition in the present disclosure and thatof a cited reference, the present disclosure controls.

1. A method of forming a prosthetic valve device for implantation into abody lumen comprising: a) forming an annular sleeve; b) affixing anannular belt to the annular sleeve, the annular belt having a bottomedge; c) providing a frame having a tubular body; d) anchoring theannular sleeve and the annular belt within the tubular body of theframe; and e) folding the annular sleeve inward upon itself along thebottom edge of the annular belt so as to form an annular inner wall andan annular cuff that is concentric to and surrounds the annular innerwall, the annular inner wall forming a fluid passageway along an axisfrom an inlet edge to an outlet edge, the bottom edge of the annularbelt adjacent to a bight portion of the annular sleeve that forms theinlet edge.
 2. The method according to claim 1, further comprising:forming a plurality of commissures in a spaced-apart arrangement about acircumference of the outlet edge; and f) anchoring the commissures tothe tubular body of the frame.
 3. The method according to claim 2,wherein the plurality of commissures are formed prior to step e).
 4. Themethod according to claim 2, wherein each of the commissures is formedby affixing a commissure strip to the annular sleeve to cinch a portionof the annular inner wall between opposing legs of the commissure strip.5. The method according to claim 4, wherein for each commissure, a cuspportion of the annular inner wall protrudes radially outward from thecommissure strip.
 6. The method according to claim 5, wherein for eachcommissure, step f) comprises anchoring the cusp portion to the tubularbody of the frame.
 7. The method according to claim 5, wherein for eachcommissure, the cusp portion is located radially inward of the tubularbody of the frame.
 8. The method according to claim 2, wherein step c)comprises forming the tubular body by cutting a pattern of slits into atube of shape memory material having a first inner diameter, andexpanding the tube of shape memory material to a tube having a secondinner diameter that is greater than the first inner diameter.
 9. Themethod according to claim 8, wherein step c) further comprisesgenerating a 2-D rendering of the pattern of slits and applying the 2-Drendering to the tube of shape memory material having a first innerdiameter, and laser cutting the slits.
 10. The method according to claim8, wherein the pattern of slits on the tube of shape memory materialhaving a first inner diameter are configured so that when the tube ofshape memory material is expanded to a tube having a second innerdiameter, the tubular body comprises a post structure for eachcommissure of the valve component and a lattice structure extendingbetween each of the post structures.
 11. The method according to claim10, wherein step f) comprises anchoring the commissures of the valvecomponent to the post structures of the tubular body.
 12. The methodaccording to claim 8, wherein the pattern of slits is formed entirely oflinear slits.
 13. The method according to claim 12, wherein each of thelattice structures comprise a plurality of open cells, and wherein allof the open cells of all of the lattice structures are a diamond-shapeor a partial diamond-shape.
 14. The method according to claim 2, whereinthe annular inner wall is free of anchoring penetrations with theexception of at the commissures.
 15. The method according to claim 1,wherein the annular sleeve and the annular belt are formed of a pliablematerial.
 16. The method according to claim 1, wherein the annularsleeve and the annular belt are formed of a material selected from thegroup consisting of a biological tissue and a biocompatible polymer. 17.The method according to claim 1, wherein the frame extends along theaxis from a bottom edge to a top edge, the inlet edge located at anaxial location between the top and bottom edges of the tubular body ofthe frame.
 18. The method according to claim 1, wherein step a)comprises rolling a single sheet of material to form the annular sleevehaving a single axial seam.
 19. The method of claim 13, wherein thediameter of the annular sleeve and is greater than the second innerdiameter of the tubular body of the frame.
 20. The method of claim 19,wherein the ratio of the diameter of the annular sleeve to the secondinner diameter of the tubular body is such that when the prostheticvalve device is delivered to the implantation site and the tubular bodyof the frame is compressed, the annular sleeve seals the plurality ofopen cells of the frame to prevents leakage of bodily fluid.